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In a recent decision, the United States Supreme Court ruled that a lateral job transfer can – in certain circumstances...

On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract...

The FDA is seeking public input on the patient safety impacts of medical software functions excluded from device regulation under the 21st Century Cures Act, including clinical decision support and remote patient monitoring tools. As the August 13, 2026 deadline approaches, stakeholders face critical questions about how small functionality differences determine whether their products are regulated devices or excluded software functions. This regulatory uncertainty creates competitive challenges and complian

The Government Accountability Office recently affirmed the Navy's authority to preserve critical manufacturing capacity through sole-source contracting, even when an incumbent contractor remains capable of meeting requirements. This decision addresses whether defense agencies must prove a manufacturer will exit the market without a contract, or whether a reasonable basis for industrial mobilization concerns suffices. The ruling has significant implications for contractors investing in specialized defense ma

On January 24, the Small Business Administration announced updated small business contracting goals for fiscal year 2025, significantly decreasing goals for small...

On January 21, in MVL, Inc., et al. v. United States, the U.S. Court of Federal Claims (COFC) struck down a 2022 Executive Order (EO), as well as the implementing Federal Acquisition Regulation (FAR)...

On September 29, the U.S. Department of Commerce Bureau of Industry and Security (BIS) issued a new interim final rule that significantly expands the scope of U.S. export controls.

The list of U.S. state-level data privacy laws will grow substantially this summer as three more comprehensive state laws become effective. Texas, Oregon and Florida...

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a "patient" of a 340B program covered entity eligible to receive a 340B drug.

FDA’s proposed rule would allow qualifying distributed manufacturing establishments (DMEs) to register as a single drug establishment under a new hub-and-spoke model, provided they operate under a single management...

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-04, approving the per-booking fees healthcare providers pay a technology company

When U.S. companies acquire foreign subsidiaries with existing business relationships in sanctioned jurisdictions, how far does American sanctions compliance extend? A recent OFAC settlement reveals the costly consequences of inadequate guidance to overseas operations and highlights critical gaps that can expose parent companies to liability for their subsidiaries' indirect sales.

The Bass, Berry & Sims Healthcare Private Equity Team is pleased to share with you our first installment of the BBS Connect Newsletter for 2024.

The Department of Justice secured a $2 million settlement with Honeywell Aerospace for allegedly failing to comply with NIST SP 800-171 cybersecurity requirements under a Department of War contract. This case demonstrates how cybersecurity compliance failures can trigger False Claims Act liability even without an actual data breach or cyberattack, and highlights the growing role of whistleblowers in exposing contractors' gaps between contractual obligations and actual security practices.

State legislatures are rapidly expanding oversight of health care transactions, with eight states enacting new laws targeting private equity involvement, MSO arrangements, and REIT transactions. These regulations introduce complex notice requirements, approval processes, and corporate practice restrictions that fundamentally alter how health care deals must be structured and timed.

This ruling clearly applies in the Southern District of New York, however, its impact outside of the district is uncertain.

Splitting from the other circuit courts, the Ninth Circuit held that while the major questions doctrine permits review of agency decisions, it is inapplicable to executive actions.

The U.S. Department of Justice announced a $21.5 million settlement with Deloitte over allegations that certain diversity, equity, and inclusion practices violated anti-discrimination requirements under federal contracts. The settlement, part of DOJ's Civil Rights Fraud Initiative, includes parallel state settlements with Indiana and Florida, demonstrating that contractors face potential False Claims Act exposure at both federal and state levels for DEI-related employment practices.